Notification of adverse reactions and serious events in trials involving medicinal products

Immediate notification of serious, unexpected and suspected adverse reactions (SUSARS) shall be made exclusively to the Danish Medicines Agency.

Once a year during the entire trial period, the sponsor or the investigator shall submit to the Committee a list of all serious unexpected and suspected adverse reactions and all serious events that have occurred during the period. The notification shall include an assessment of the safety of the trial subjects.

It should be noted that

· Notification of adverse reactions must relate to the approved research project and not only to e.g. a substance that may have been tested in several projects or e.g. tested only outside the territory of Denmark

· The observations may be submitted electronically, e.g. on a CD-ROM

· The observations must be in Danish

· The investigator’s evaluation of the adverse reactions encountered shall appear from the material submitted

In so far as concerns the content of the list of adverse reactions, the Committee will follow the guidelines from the Danish Medicines Agency.

Notification of adverse reactions and serious events in trials NOT involving medicinal products.